I. Peer-Review Process
How long does the peer-review process take?
Once the Draft Final Research Report (DFRR) enters external peer review, the process will take about six months. This includes review by external reviewers and associate editor, two months for the author’s response and up to two more revisions. The peer-review process may take longer if there are delays in submitting revisions.
Peer Review Timeline
How much time and resources should I set aside to write and revise the Draft Final Research Report?
PCORI recommends that you start preparing the DFRR at least one year before the due date by writing the Background, Patient and Stakeholder Engagement, and Methods sections before you have your results. Preparing the report and responding to reviewer comments can take around 100 hours over the seven to eight months estimated in the timeline. Be sure that you have set aside time to complete this work as well as ensure access to an assistant to compile materials and a statistician to help write the Methods section on statistical analysis and address reviewer comments. You will not be required to do new statistical analyses, but you may be asked to provide more information about the analyses presented in your report.
How will authors get the results of the peer review?
The corresponding author will receive email notifications from our peer-review submission system, ReView (from Origin-PCORI Peer-Review address), when editor and reviewer comments are ready to be viewed. Authors will need to log into ReView to review the comments and any edited copies of their DFRR. If the authors have questions, they should contact [email protected].
How long do awardees have to respond to reviewers’ comments?
As noted in PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings, awardees have 45 business days (about two months) to respond to external reviewers’ comments. However, we are willing to work with awardees to adjust these deadlines as circumstances arise. If editors request additional revisions, awardees will have two to four weeks to respond, depending on the extent of the revisions.
I can’t complete my responses to peer review before the revisions are due. What should I do?
We understand that research, clinical, administrative, and personal responsibilities can interfere with your ability to complete your revisions on time. If you feel that you need more time for revision, please contact [email protected] to request an extension. Ask for a realistic extension but also consider that you must complete peer review before your PCORI contract ends. If there are specific comments from reviewers that are causing delays in revisions, the associate editor assigned to your report as well as PCORI programmatic staff will be happy to discuss how to address the reviews.
Who do I contact for questions?
The PCORI peer-review office and peer-review contractor are available to answer your questions and help improve your peer-review experience. You are likely to find answers to your questions by reviewing material on the https://originreview.org/ website. If you cannot find the information, the peer-review contractor office ([email protected]) responds to any technical questions such as using the ReView peer-review system and alerts your associate editor regarding your scientific questions. If you would like to speak directly to any PCORI peer-review staff and contractor personnel, contact the Author Services team at [email protected].
In general, the PCORI peer-review office ([email protected]) handles requests for extensions on your report revision deadline and all communications related to the formatting, copyediting and posting of your Final Research Report once it is accepted. However, requests for changes of original submission date or requests for additional funding should go directly to your science program officer and associate.
II. Preparing Draft Final Research Reports
What results have to be included in the DFRR?
The DFRR must include all the research that PCORI funded you to complete. This should include the background, methods and results for all specific aims and any exploratory analyses that your program officer approved. If any work is missing from the DFRR, it will be considered incomplete and fail to meet your contractual requirement to submit this report.
My DFRR is due, but I haven’t finished all of my analyses. Can I add the rest of the results later during peer review?
No. The DFRR must include a complete account of all analyses and results when it is submitted. The report will be checked for completeness before entering peer review. Incomplete reports will be returned to the principal investigator. You will not have met the contract milestone for submitting the DFRR unless it is complete.
What is the difference between the final progress report and the DFRR? Both are due at the end of the study.
The final progress report documents the final phase of the study. It includes how the study was completed; whether the team met the milestones set forth in the contract; any challenges encountered; remedial actions taken in mitigating and resolving concerns, including risks to study completion; and notable accomplishments. Study findings are not typically included in the final progress report. PCORI staff review the final progress report, but it is not publicly disclosed.
In contrast, the DFRR documents all the work completed in the PCORI-funded study. This report must include a detailed description of the study’s background, engagement efforts, methods, results and conclusions, consistent with PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings. The DFRR goes through external peer review, and the awardee may revise it before PCORI accepts it as the Final Research Report (FRR). This FRR will be posted on the PCORI website on the project’s web page. It will be freely accessible and available for anyone to use.
What can be included in the appendices and how many appendices can I include?
There is no limit to the number of appendices you can include with your DFRR. However, all appendices must be referenced in the report narrative and serve a purpose in explicating elements of the report. Common uses for appendices have been copies of intervention materials and manuals; additional, post hoc data analyses; and data codebooks. The appendices are separate from the required attachments to be submitted with the DFRR. The Instructions to Awardees provide more detail on how to submit appendices and these required attachments.
How polished must the DFRR be?
The FRR will be publicly accessible on the PCORI website. Therefore, the DFRR should be as polished as if it were being submitted to your preferred journal. Please follow the formatting guidelines outlined in the Instructions to Awardees. The submitted DFRR should be carefully edited to ensure the report is clear and understandable. It should include all analyses and results planned in the study protocol and statistical analysis plan. If the report does not meet the submission requirements, it will be returned for revisions before moving forward to review. The Author Services team can help you ensure you have prepared the report and related materials correctly. Contact the Author Services team at [email protected].
Can I see examples of FRRs?
We encourage you to review FRRs that have already been posted to get a better understanding of our expectations. You can search for completed projects with posted final reports in Explore Our Portfolio, or select reports from this list.
Manuscripts with our study’s main findings have been peer reviewed and published in a journal. Can I submit my published article as my report?
No, but you may incorporate parts of published manuscripts as described below. The DFRR must follow the Instructions to Awardees to be considered adequate for peer review. Peer-reviewed journal articles also tend to focus on only part of the research conducted in a funded study, whereas the DFRR should include a full accounting of the methods and analyses planned in the study protocol. The word count of the DFRR is similar to the combined word count of three to five regular journal articles (maximum length of 15,000 words).
Can I use parts of the published manuscript in the DFRR, such as previously published tables and figures?
Yes. The DFRR can include information such as tables, figures, and sections of text from previously published journal articles (see the Instructions to Awardees for detailed instructions for including these materials). You should cite the source of material taken directly from such publications (i.e., figures, tables, and text). Awardees are responsible for checking with the journal publisher and, if necessary, obtaining permission for reprinting or using any part of the published article in the DFRR, which will be made publicly available on PCORI’s website following peer review. Authors should comply with all of the stipulations set by the journal publisher. Please note that the permissible use of previously published content may depend on the length of text and whether the authors transferred copyright to the journal. Please include a copy of any relevant copyright permissions or licenses for PCORI’s records as a separate file with your submission of the DFRR. Remember that the author, not PCORI, is liable for any unauthorized duplication of material from previously published articles.
Can I use my study protocol as part of the DFRR?
Yes. If you add your study protocol or PCORI-approved research plan as an appendix to the final report, you can skip adding the same information in your DFRR and instead refer to the relevant sections of your protocol. The protocol or research plan version you submit should be the final PCORI-approved version, which would recount the actual methods used in the study. There is more information about referencing the study protocol or research plan in the Instructions to Awardees.
Who counts as an author for the DFRR?
You can make the decision about who to include as an author on the report, however you should follow standard guidelines about who should be considered an author. Each author should meet the following International Committee of Medical and Journal Editors (ICMJE) authorship requirements:
- Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work
- Drafting the work or revising it critically for important intellectual content
- Final approval of the version to be published
- Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved
Source: International Committee of Medical and Journal Editors (May, 2022), “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.” https://www.icmje.org/icmje-recommendations.pdf
More information about our authorship guidelines can be found at https://originreview.org/authorship-policies/. Remember that the principal investigator and their institution are responsible for collecting and attesting to the conflict-of-interest information from all listed authors, including authors at different institutions.
III. Completing the Ancillary Information Conflict of Interest (COI) Disclosure Form
Who needs to complete and sign the Ancillary COI Disclosure Form?
The Ancillary Information COI Disclosure Form captures COI information related to the study and FRR as listed in our authorizing law:
--PUBLIC AVAILABILITY. —The Institute shall make available to the public and disclose through the official public Internet website of the Institute the following: …The process and methods for the conduct of research, including the identity of the entity and the investigators conduc[t]ing such research and any conflicts of interests of such parties, any direct or indirect links the entity has to industry, and research protocols, including measures taken, methods of research and analysis, research results, and such other information the Institute determines appropriate concurrent with the release of research findings. [42 U.S.C. § 1320e(h)(3), italics added for emphasis.]
The institution that received the study funding (i.e., awardee institution) is responsible for completing the COI form and verifying whether any key personnel on the project have a conflict of interest related to the research project. The principal investigator and an administrative official from the awardee institution must sign the COI form for it to be considered complete.
What does PCORI consider to be a conflict of interest?
PCORI has modeled aspects of the COI form based on the National Institutes of Health Grants & Funding policy. For more information on this policy, please visit https://grants.nih.gov/grants/policy/coi/index.htm.
A conflict of interest is defined as any financial or business associations or personal associations related to health care (e.g., if you or someone in your immediate family has worked for or volunteered for a healthcare-related organization, holds a patent for a medical device, or owns an individual stock in a medical product manufacturing company).
Do all key personnel from the study have to be on the same COI form?
All current key personnel on the research project, even those from institutions other than the sponsoring institution, should be listed on the same COI form, even if they are not all listed as authors on the DFRR. If you have had any changes in key personnel, please inform your assigned program officer or program associate so they can make the appropriate updates in the project record. The institution completing the COI form can add extra pages if they need additional space.
Do awardees have to submit their COI form at the same time as the DFRR?
In general, awardees should submit their COI form at the same time as their DFRR. However, PCORI understands that different institutions have different processes for signing off on conflict disclosure documentation. If the COI form is not complete by the time you are due to submit your DFRR, please notify the PCORI Peer-Review Office ([email protected]).
IV. Posting of Peer-Reviewed Materials
What will be posted on PCORI’s website after the peer-review process is complete, and when will it be posted?
As noted in PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings document, approved by the Board of Governors, PCORI will post the following within 90 days (three months) of accepting the FRR:
- A public-facing research summary developed by the PCOR Translation Center after review by the awardee (with audio and Spanish translations available)
- A 500-word abstract for medical professionals, also developed by the Translation Center.
- A link to the study results tables on ClinicalTrials.gov (as applicable)
- Ancillary information: completed COI Disclosure Form
Within 12 months of accepting the FRR, PCORI will post the following:
- A summary of the major peer-review comments and author responses
- The FRR with accompanying appendices
- The final study protocol
What information is posted online about the peer review of the DFRR?
As with any peer-review process, the editors and content experts who review the DFRRs often ask the researchers to address concerns about the way they conducted the project, their results and their conclusions. PCORI will prepare a summary of three to five points from peer review, including what reviewers commented and how the authors responded. The peer-review summary will be posted on the project’s PCORI web page to help readers understand what changed in the report as a result of the peer-review process.
The peer-review summary will also describe any review concerns that were not fully addressed by the researchers. When the peer-review summary includes unresolved concerns, we will invite the report authors to submit a brief explanation of their reasoning. We limit such statements to 200 words, and they are subject to review by PCORI program staff. Any such awardee response will be posted online with the peer-review summary.
Awardees can request to review the peer-review summary. We do not expect awardees to ask to write a response to the peer-review summary when there are no unresolved issues. But if an awardee does so or asks for changes to the summary to make the language clearer, we will consider such requests on a case-by-case basis.
After the Final Research Report is posted to the PCORI website, may awardees request changes to the report?
Yes, requests to correct errors or change results so that they align with findings published elsewhere are allowed. If you want to change something in your FRR, contact [email protected] to discuss the extent of the changes. If there are errors in the FRR we will remove the report from our website until you correct them. Before reposting, we will review all proposed changes to determine whether the report needs to go back to the associate editor for re-review if there is a significant change to the final report or any changes to the study conclusions.
Before posting the revised FRR, PCORI will add an erratum statement after the title page to explain and date the changes and update the recommended citation and copyright statement to note the year of reposting.
Is posting results tables to ClinicalTrials.gov considered prior publication? What about the summaries or abstracts posted on PCORI’s website?
Most journals do not consider posting of results on a registry like ClinicalTrials.gov or in summaries of 500 words or less to be prior publication. Our policy regarding the posting of these results conforms to the recommendations of the ICMJE: “The ICMJE will not consider as prior publication the posting of trial results…if results are limited to a brief (500 word) structured abstract or tables (to include patients enrolled, key outcomes, and adverse events).”
Please let the PCORI peer-review office know if a journal editor raises concerns so that we can contact him or her directly to discuss them.
Similarly, the ICMJE does not consider as prior publication the author’s requirements under the Food and Drug Administration Amendments Act of 2007, U.S. Public Law 110-85, Title VIII, to post results tables on ClinicalTrials.gov. For more information, see:
- ICMJE Statement: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
- ICMJE FAQ: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
Are there any restrictions on where awardees can publish articles based on PCORI-funded research? For example, are awardees expected to publish only in open-access journals?
Awardees may publish articles resulting from PCORI-funded projects in any journal at any time. We expect that awardees will notify us when they submit manuscripts to journals and when journals accept those manuscripts for publication. We also ask that awardees inquire about open-access options because of our interest in linking to the published articles from our website. For more information about PCORI’s policy, please refer to Public Access to Journal Articles Presenting Findings from PCORI-Funded Research.
If the Final Research Report posts no later than 12 months after acceptance, what will happen if a manuscript describing that work is being considered for publication in a peer-reviewed journal? Most journals require that the information in submitted manuscripts not be published previously.
PCORI will work closely with awardees, investigators and journals to coordinate posting of the FRR with publication of manuscripts in press. However, we must balance journal publication with our obligation under our authorizing law, affirmed through public comments on our draft Peer-Review Process document, to make the results of PCORI-funded research widely available to the public as expeditiously as possible. The document states, “PCORI may delay posting beyond 12 months to coordinate posting with publication of a peer-reviewed journal version of study findings.” We will post the FRR at 12 months unless the author has received a revise and resubmit letter from the journal.
Posted: March 27, 2017; Updated: November 3, 2023
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